Clinical Trial Supply Management: A virtual company’s lessons learned
Bruce H Morimoto, Ph.D.May 30, 2013
Disclaimer
The views expressed in this presentation are mine and do not reflect those of my past, present or future employers…
Senior Management View of CTS
Labeling Drug Depot
Clinical Sites
Drug Manufacturing
What’s so difficult? Devil is in the details…
IMP Characteristics
Refrigerated storage product Stability OK for up to 1M at RT Not stable at > 40°C
Very expensive per unit cost Limited supply (only 10% overage) On-going stability—retest updates
Clinical Trial Parameters
48 sites, 6 countries, 3 continents
Study duration: 12 month
Recruitment: 9-12 months
~300 subjects total
0.5 subjects per month per site
IMP in 3 month kits
IMP-Driven Decisions
Cold chain supply
Refrigerated shipping
Shipments needed to be temperature monitored
Just-in-time shipping
Couldn’t keep inventory at sites
Randomization would trigger shipping
Trial-Driven Decisions
Product manufactured in North America
Continents
North America
Europe
Asia-Pacific
All countries in Europe part of EU (!)
Single QP release for all of Europe
(Idealized) Product Flow
Labeling & Packaging
(EU)
Drug Depot (US)
Clinicalsites
Drug Manufacturing
(North America)QP Release
Drug Depot (EU) Drug Depot (Asia-Pacific)
Clinicalsites
Clinicalsites
Actual Product Flow
Drug Depot (US)
Labeling & Packaging
Active(EU)
Clinicalsites
Bulk Drug (EU)
QP Release
Drug Depot (EU)
Drug Depot (Asia-Pacific)
Clinicalsites
Clinicalsites
Labeling & Packaging Placebo
(NA)
Drug Manufacturing (North America)
Logistic Challenges
Customs Multiple QP release Volcanic eruptions
Find a customs broker—upfront! Got bill for $200K We were able to get most of it back, but…
Shipping-logistics expert (consultant)
Case Challenge
Had 3 year stability on old formulation Changed IMP formulation IMP retest date driven by real-time stability
Get stability data from manufacturer Update IMPD Submit to European country authorities with proposed
retest extension Receive approval Release newly labeled IMP into inventory
Shipped 3 month supply
Lessons Learned
Have enough stability BEFORE you begin Map out supply chain and plan for contingencies
Independent person to track and review inventory &
retest dates
Person needed to be unblinded to track placebo &
active kits
Required excellent coordination with regulatory
Other Learning Discussions
Shipping:
Premium provider versus Standard Courier
Just-in-time shipping versus inventory at sites
Cost of drug and availability
Cost of each shipment
Temperature monitoring
Bulk shipments versus Individual shipments
Temperature monitors versus warmmarks
Special Thank You to:Tracey JoellLiam Quinn
Lesley ParkerSue Anne Crocker
Mina Virtusio
Questions? Please email: [email protected]
Questions?
